DexCom, Inc.

The story coming out of Abbott Laboratories for 4Q25 was less than stellar. The Abbott Park, IL-based company saw its shares trade down as much as 10% after missing sales estimates by 3%. The softness in sales came mostly from the company’s nutrition segment. However, there were some bright spots in the earnings. The company reported total revenue of approximately $11.5 billion for 4Q25; however, this fell short of consensus estimates of $11.8 billion. Abbott saw its medical device sales grow by 10% in the quarter, with pulsed-field ablation and diabetes offerings pushing it forward. Abbott is facing intense competition in both of these markets. In PFA, Boston Scientific, Johnson & Johnson, and Medtronic are gobbling up share. Abbott Chairman, CEO, and President Robert Ford said, according to a Seeking Alpha transcript of the call, “In electrophysiology, sales grew double digits in the U.S. and internationally.  In December, we announced FDA approval of our Volt PFA catheter , which represents our first PFA product offering in the United States.” Sales of Continuous Glucose Monitors grew by about 12.2%. However, BTIG analyst Marie Thibault noted the company experienced lighter-than-expected Libre sales of $2 billion. The CGM market, while rapidly growing, is highly competitive. Abbott is facing intense pressure in the space from Dexcom, as both launched over-the-counter CGM technology around the same time. “In Diabetes Care, sales of continuous glucose monitors grew 12% in the fourth quarter and 17% for the year, with sales in 2025 exceeding $7.5 billion,” Ford said, according to a Seeking Alpha transcript of the call. “This marks the third consecutive year that our CGM sales have grown by more than $1 billion. Our success in CGM continues to be driven by strong underlying market fundamentals, a leading position in cost and scale, and an unwavering commitment for market-leading innovation. These factors have led to a continued increase in adoption across all of the various user groups.” The report of the revenue miss follows Abbott announcing it would acquire Exact Sciences , a molecular diagnostics company that specializes in the detection of early-stage cancers. “Our announced acquisition of Exact Sciences will allow Abbott to enter and lead in the fast-growing cancer diagnostics market and adds a new high-growth business with an attractive pipeline to the Abbott portfolio,” Ford said, according to a Seeking Alpha transcript of the call. In a research note, William Blair Analyst Andrew Brackman wrote, “Overall, this was not a clean update, with the latest hiccup in nutrition following a revenue guide down in the second quarter and an acquisition of Exact Sciences, which has received mixed feedback from certain investors. This makes the Abbott story less clean than investors are used to.” Marie Thibault, a BTIG analyst, wrote, “We understand the reaction, as nearly all segments underperformed Q4 expectations, the devices business was not the bright spot it typically is, and the 2026 sales guide was below consensus. Much of this is related to the Nutrition segment, where Abbott called out disappointing consumer demand and volumes as a result of pricing that had been increasing in recent years. The company is reducing its prices, using promotions, and will release new products this year, but 1H26 is expected to remain weak for Nutrition.” Thibault added, “In Devices, we think the minor miss this quarter will keep investors focused on the health of the underlying Medtech market. Abbott management emphasized that Q4 volumes were 'really good' across all categories.”

South Korean Woori IO, a developer of noninvasive continuous glucose monitors, believes new FDA rules regarding wearables will accelerate the company’s commercialization process. Woori, which was recently acquired by OSR Holdings, plans to launch first in the consumer wellness wearables category before expanding to the medical grade space. In January, FDA announced plans to limit regulation of wearable medical devices. The move has been celebrated by manufacturers in the space, who largely believe this will accelerate the market even more over the next 12 months. Currently, the majority of fitness tracking wearables and fitness apps are classified as non-medical devices, meaning they are already exempt from strict regulations. New FDA policy will add to this existing policy, taking an even more limited regulatory approach towards companies like Apple, Whoop, FitBit, and Oura. The majority of wearable medical devices do not make claims related to disease diagnosis or treatment, and tend to track metrics like sleep, calories burned, and daily stress. FDA Commissioner Marty Makary did clarify that if companies make a wearable device that claims to be “medical grade,” tracking markers like blood pressure, they will be more strictly regulated by the agency. Following this announcement, shares of CGM manufacturers Abbott, Medtronic, and Dexcom rose between 1% and 4%. Several major device companies have set their sights on the development of non-invasive CGM’s over the last several years, as the blood glucose monitoring devices market is expected to exceed $40 billion by 2030. This is predicted to be driven by noninvasive and wearable CGMs. Woori IO believes this new regulatory clarity will accelerate time-to-market for the company, which plans to first launch consumer-grade, lifestyle-management wearable solutions, while continuing its longer-term development roadmap toward medical-grade CGM systems. During phase one of its long-term strategy, Woori will release products and software features that are intended to provide noninvasive, glucose-related insights for lifestyle, nutrition, and activity management. Under new FDA regulations, Woori will be able to accelerate its go-to-market time for phase one, since such devices won’t be faced with scrutiny from regulatory agencies. The company plans to position these offerings as “general wellness tools” that are not intended for diagnose, treat, or sway clinical decision-making. During the second phase of its commercialization plan, Woori plans to launch devices that deliver clinically actionable glucose data for diabetes management, either via smartwatch-integrated systems or Woori IO's own standalone wearable platforms. Due to the clinically actionable nature, these devices will be subject to FDA scrutiny. The company believes that early integration as a consumer wellness feature provides a scalable entry point to market while longer-term medical validation proceeds. New FDA rules allow companies to decouple commercialization from longer medical-device approval timelines without compromising scientific rigor or future regulatory objectives. By launching first in the consumer wellness category, Woori plans to accelerate user adoption, generate real-world performance data, and deepen its existing partnerships, while maintaining a clear pathway toward regulated medical applications. "We view the FDA's clarification as a meaningful development," Sunkie Park, CEO of Woori IO, said in a prepared statement. "It supports responsible innovation by clearly distinguishing wellness insights from regulated medical claims, enabling faster market entry while we continue investing in clinical validation."

SAN FRANCISCO – Jake Leach, the new CEO of glucose-monitoring company Dexcom , sat down with MobiHealthNews outside the JPM Healthcare Conference to discuss his vision for the company and how AI and wearables are shaping healthcare. MobiHealthNews: What are your plans moving forward as Dexcom's new CEO? Is anything going to change? Jake Leach: I'm going to build on the fantastic legacy that Kevin [Sayer] ... and I worked for him for the entire time that he was at Dexcom, and he was CEO for more than a decade. ... A lot of the significant growth in the category and at Dexcom was all under his leadership. So I'm going to really build on that foundation and lean on my background as an engineer. I really value problem-solving, being precise and continuous improvement. We're going to build the next chapter on innovation by focusing on customers and really making sure that we are understanding what we can do to drive the innovation and what's important for users, and really broaden the access to CGMs [continuous glucose monitors]. There are so many people in the world who could benefit who don't have either coverage or even access to it, cash pay even. So there's a lot of opportunity for us to make a huge impact. And so that's really going to be my focus: How do we get this product in the hands of more people? MHN: There is a lot of talk about longevity nowadays. What are your thoughts on how wearables are going to help improve preventive care? Leach: The No. 1 thing that wearables do is they provide the individual with the information. So it's very empowering. With CGM, what we've seen is that even with very little instruction, when a user starts seeing real-time glucose data, they start understanding a whole lot more about their food and activity levels and how things impact their body. It's the same with the Oura Ring. I mean, I use it all the time. I definitely try to do a better job sleeping, although lately it's been a little tough, but it helps me prioritize the regenerative sleep that I need to keep going. And so you start combining those signals, which is the whole idea of our partnership with Oura, is combining the experiences of the two technologies to give users more insights. Diabetes is impacting so many people around the world, so empowering users. It's a disease that you can make significant progress against if you have the right tools, and CGM is an amazing tool for that. So I think we're going to continue to see expansion in wearables and new capabilities. And you know, the FDA just came out with some new information around, you know, kind of opening up the regulation and making it a little easier for some of the noninvasive trackers to be able to move things forward. And I think that proactive, innovative purchases from everybody, whether it's the industry or the regulators, are important for driving innovation and new use cases. MHN: It is anticipated that millions of people will lose their healthcare coverage in 2026 because of changes to federal policies. Do you think AI and wearables can help close the gap in access to healthcare, enabling consumers to gain more insights into their health and take ownership of it? Leach: In general, when you think about wearables and CGM, we certainly have programs designed for people when they do lose healthcare. [Dexcom] actually has a patient assistance program, specifically designed for people, if you have coverage and you lose coverage, whether it's Medicaid or any other program, we will help you and assist in getting a CGM for a low out-of-pocket cost. And it's really just something that we do because we hate to see that happen. But, in general, I do think that it is going to take a little while. I mean, AI innovation is pretty unbelievable. The pace of innovation ... what we did a year ago with it, and what is happening now. I do think when it comes to truly saving costs and being able to drive more access to healthcare, it's gonna take a little while. I think we're all working with AI. We're all leaning into [it]. How do we use it to enhance the solutions and make our systems more scalable for more people? But I do think it's going to take a little while. It's not going to be right away. But as I look at outcome-based medicine, I mean, if you look at the outcomes that we can drive with CGM, we are very excited about opportunities to prove what we can do with a wearable for someone, and ultimately, we have shown time and time again that Dexcom CGM will save payers money in the first year if they put somebody on it because they don't show up in the emergency room with either low or high glucose. They aren't using the healthcare resources as much because they have the tools they need, and their management of diabetes is more healthy.